PIB for Post-operative Analgesia After Laparotomy : Determining the Optimum Dose
Status:
Not yet recruiting
Trial end date:
2024-03-01
Target enrollment:
Participant gender:
Summary
Pain control after surgery is a major factor in the patient's quality of recovery. In open
abdominal and gynecologic surgery, TEA (Thoracic epidural analgesia) are installed when
feasible to freeze pain signaling from the surgical site and decrease the patient's pain
level.
After installation, medication has historically been infused as a CEI (continuous epidural
infusion). However, more and more anesthesiologists prescribe PIEB (Programmed intermittent
epidural boluses) instead of continuous infusion, with the intent of offering better
analgesia. In both cases, patient-controlled epidural analgesia is also prescribed, which
allows the patient to auto-administer additional boluses of local anesthetics.
Despite many studies demonstrating benefits in the obstetrical population, only a few studies
in the recent years have been completed regarding the advantage of PIEB for patients
undergoing open abdominal and gynecologic surgeries. They yielded conflicting results. Some
concluded in a benefit from PIEB, while others demonstrated no difference. Either way, PIEB
showed to be at least as effective in controlling pain as CEI, confirming the clinical
decision of prescribing the former.
Keeping the effectiveness of it in mind, dosage has however never been tested and is
currently prescribed empirically. This would be the main objective of this study.
Using a biased coin up-down sequential allocation method, we will conduct a clinical trial to
identify the optimal dosage of low-dose bupivacaine using a PIEB protocol. We believe that
the said dosage to achieve successful analgesia should be in the interval of 5 to 10 ml every
60 minutes. Therefore, the doses that will be tested will be 5, 6, 7, 8, 9 and 10 ml every 60
minutes, corresponding respectively to groups 5, 6, 7, 8, 9 and 10.
Our primary outcome will be measured post-op day 1. Successful analgesia will be defined as 5
or less PCEA boluses during those hours.
Secondary outcomes will be the incidence of motor block and hypotension, comparison of the
level of sensory block according to group, comparison of patient satisfaction according to
group and comparison of Quality of Recovery-15 score at 48h post-op according to group.